osstell.com

USER MANUALOsstell Beacon

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2) Warnings and PrecautionsWarnings:

Read all instructions before operating the Osstell Beacon.

Theinstrumentemitsanalternatingmagneticfieldthatpoten-tially could interfere with cardiac pacemakers! Keep the instru-ment away from implanted electronic devices. Do not place the instrument on the patient’s body.

A transparent, barrier sleeve must be used to cover the Osstell Beacon when used on patients. See section 11 for recommend-ed sleeves and section 15 for information on recommended cleaning.

Do not autoclave the instrument.

The SmartPeg Mount must be sterilized before use.

Theinstrumentwillflashred-yellow-greenduringstart-upasa functional test of the color indication. If any or all colors are not shown, the instrument must not be used. Contact the local sales representative or distributor for further instructions.

Always perform a measurement in two directions, Buccal-lingual and Mesial-Distal, as guided by the instrument. This is impor-tant to detect the lowest implant stability.

The SmartPegs™ are disposable and should only be used for one or multiple measurements at one treatment session, for a single patient only (to avoid cross-contamination). Repeated re-use may result in false readings due to wear and tear of the softaluminumSmartPegthreads.

Table of content1) Table of content 22) Warnings and Precautions 33) Intended Use 34) Indications for Use 35) Description 36) Safety Symbols 47) Before You Start 58) Operation of the Osstell Beacon Instrument 59) TestPeg 510) SmartPeg 6 11) How to Measure 6 12) How to Measure on an Abutment 713) Interpret the Result 714) Data Connection to Osstell Connect 815) Cleaning and Maintenance 816) Technical information 917) Troubleshooting 1018) Service and Support 1119) Waste and Disposal 11

Welcome

Congratulations on the purchase of your new Osstell® Beacon. Before you start using your Osstell Beacon, please read through the entire manual.

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Do not expose the instrument to extreme high temp, e.g. leaving it in the car dashboard on a warm sunny day.

TheOsstellBeaconisnotprotectedfromingressoffluids,e.g.water,attheUSBconnector(IP20classified).

Mains-operated power supplies or USB cable used for charging, shall not be reachable by the patient.

Precautions:

To avoid interference with other equipment, the instrument should not be held close to electronic devices.

Onlyusetheacceptablecleaningfluidslistedinsection15 when cleaning the instrument.

Do not use the instrument in the presence of explosive or flammablematerials.

See section 4, 5 and 10 for information about approved and compatible accessories.

3) Intended UseOsstell Beacon is intended for use as a Dental Implant StabilityAnalyzer.

4) Indication for useOsstell Beacon is indicated for use in measuring the stability ofimplants in the oral cavity and craniofacial region.

ConditionsSurgically placed implants or abutments for which there is space to attach a compatible SmartPeg.

Reasons for useThe Osstell Beacon can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluationprogram.Thefinalimplanttreatmentdecisionsaretheresponsibility of the clinician.

Contraindications Osstell Beacon is contraindicated for implant systems to which the SmartPeg could not be attached for mechanical incompatibility reasons. See section 10 for more information about SmartPegs.Osstell Beacon is contraindicated when used together with Pegs not approved by Osstell. Osstell Beacon is contraindicated where it is not possible to attach the SmartPeg due to lack of space, or where it impingesonotherartificialoranatomicalstructures.

5) DescriptionThe Osstell Beacon is a handheld instrument that involves the use of the non-invasive technique, Resonance Frequency Analysis. The system involves the use of a SmartPeg attached to the dental implant or abutment by means of an integrated screw. The Smart-Peg is excited by a magnetic pulse from the instrument tip.

The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed on the instrument as the Implant Stability Quotient (ISQ). The ISQ is scaled from 1 to 100. It is a measurement of the stability of the implant and is derived from the resonance frequency value obtained from the SmartPeg. The higher the number, the greater the stability. The instrumentsoftwarecanbeupdatedbyusingtheOsstellUSBcable.

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Caution

Follow instructions for use

Consult instructions for use

See section 2) Warnings and Precautions

Type BF applied part

Manufacturer

YYYY-MM-DD

Date of manufacture

SN Serial number

Do not dispose of with domestic waste. Li-ion battery.

CEmarkwithidentificationnumberofthenotifiedbody.

This electronic product is approved by Federal Communications Comission (FCC)FCC ID: QOQBLE113 IC: 5123A-BGTBLE113

Non-ionizing electromagnetic radiation

Not Sterilizable

Temperature limitation

Humidity limitation

Atmospheric pressure limitation

6) Safety Symbols

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Your Osstell Beacon system includes the following items:

1 Osstell Beacon Instrument2 Osstell USB cable3 Osstell SmartPeg Mount4 Osstell TestPeg5 Osstell Key6 Osstell Beacon Manual

Applied Parts: Osstell Beacon instrument tip and thin part of body.

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IP20 Protected against solid foreign objects of 12.5mm ∅ and greater. No protection against water.

Use by date

Lot/batch code

Sterilized using irradiation

RX-Only

For US market only: Prescription use only. U.S. Federal Law restricts this device to sale by or on the order of a licensed practitioner

REF Catalog Number

2 Do not reuse

7) Before You Start The Osstell Beacon is delivered from factory in a “transport” mode, where the built-in motion sensor is deactivated.To de-activate the transport mode and start charging, connect the small USB connector of the Osstell USB cable to wide end of the instrument. Connect the large USB connector to a standard USB type A outlet of a PC, laptop or charger.The Osstell Beacon will start-up and enter charging mode. Charge the Osstell Beacon for at least 3 hours or until the Osstell Beacon indicates full charge. Remove the Osstell USB cable.Note! It is not possible to perform an ISQ measurement duringcharging.

8) Operation of the Osstell Beacon InstrumentThe Osstell Beacon is activated by a built-in motion sensor. As soon as the motion sensor detects movement, the Osstell Beacon will start-up,flashred-yellow-greenandshortlyshowbatterystatusin the lower display and then be ready for measurement in the BL (Buccal – Lingual) direction, which is indicated in the upper display.

The Osstell Beacon will start to measure, indicated by an audible sound, when near an Osstell Smartpeg or Testpeg due to a built-in magnetic detector that senses the magnet on the top of the Osstell Smartpeg/TestPeg. Measured data will be shown in the upper display combined with a colored light indication below the instrument tip.

The red, yellow and green color represents low, medium or high implantstability.After60secondsofnomotion,theOsstellBeaconwillturnoffautomatically.

9) TestPegThe Osstell TestPeg may be used for testing and learning how to use the system. Place the Osstell TestPeg on the table or hold it in your hand. Activate the Osstell Beacon by moving it and hold the instrument tip approximately 3-5mm away from the top of the Osstell TestPeg. The Osstell Beacon should start to measure and present an ISQ value of 55 +/- 2 ISQ.

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10) SmartPegTheSmartPegisavailablewithdifferentconnectiongeometriestofitallmajorimplantproductsonthemarket.Youcanfindall available SmartPegs on osstell.com/smartpegguide.The SmartPegs™ are disposable and should only be used for one or multiple measurement at one treatment session, for a single patient only (to avoid cross-contamination). Repeated re-use may resultinfalsereadingsduetowearandtearofthesoftaluminiumSmartPeg threads.

11) How to MeasurePrior to use on a patient, place a barrier sleeve over the Osstell Beacon. The barrier sleeve helps prevent cross-contamination and helps keep dental composite material from adhering to the surface of the instrument tip and body, and discoloration and degradations from cleaning solutions.

Note: • Barrier sleeves are single patient use only.•Discardusedbarriersleevesinstandardwasteaftereachpatient.• Do not leave barrier sleeves on the instrument for extended periods.• See below for recommended barrier sleeves. TIDIshield, Art no: 21021, Art no: 20987. www.tidiproducts.com PremiumPlus: 123, Small short 123, Small Please also see additional recommended barrier sleeves on:

osstell.com/get-started-beacon• The Osstell Beacon instrument must be cleaned and sanitized withappropriatecleaningand/orsanitizingagentsaftereachpatient. See section 15) Cleaning and Maintenance for acceptable agents.

Afirstmeasurementshouldbetakenatimplantplacementtogetabaseline for future measurements throughout the healing process. Beforethefinalrestoration,anothermeasurementistakenwhichmakes it possible to observe the stability development of the implant.

It is recommended to measure in both Buccal-Lingual and Mesial- Distaldirectiontofindtheloweststability.Therefore,theOsstellBeacon prompts the user to measure in both these directions.We recommend you studying the more detailed information (videos and quick guides) available on osstell.com/get-started-beacon, to utilize the full functionality of your Osstell Beacon.

1. Activate the Osstell Beacon by picking it up. The instrument will start-upandaftershowingthebatterystatus,theinstrumentwillbe ready for measurement in the BL (Buccal – Lingual) direction, which is prompted in the upper display as well as optimal angle of the instrument tip towards the Smartpeg.

2. Place a barrier sleeve over the Osstell Beacon instrument. See fig 1.3. Place the SmartPeg into the SmartPeg Mount. The SmartPeg is

magnetic, and the SmartPeg Mount will hold the SmartPeg. See fig 2. Attach the SmartPeg to the implant or abutment by screwing the SmartPegMountusingfingerforceofapproximately4-6Ncm. Do not over-tighten, to avoid damaging the SmartPeg threads.

4. Hold the instrument tip close (3-5mm) to the top of the SmartPeg without touching it. An audible sound indicates when measure-ment has started, and measured data will be shown in the upper display combined with a colored light indication below the instrument tip. Bring the instrument out of the mouth to clearly read the ISQ value and the colored indication.

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The measured ISQ values will be displayed in the upper display for a couple of seconds and then switch to indicate ready for measurement in mesial-distal direction. See fig 3 and 4. Note! Do not bring the instrument tip to the SmartPeg until the upper display has switched to next direction.

5. Do not measure from above. See fig 5.

6. Repeat step 4 and the sequence starts over and the Osstell Beacon is ready for measurement in the BL (Buccal- Lingual) direction again. See fig 3.

7. When all measurements are performed, remove the SmartPeg by using the SmartPeg Mount.

8.Theinstrumentisautomaticallyturnedoffafter60secondsofnomotion.

12) How to Measure on an AbutmentWhen a measurement is made on an abutment or on an implant with a “built-in” abutment, the ISQ value will be lower compared to ameasurementmadeontheimplant.Thisisduetothedifferenceinheightabovebonelevel.TofindouttheISQdifferencetothemeasurement performed at implant level, a measurement should be taken on the implant before the abutment is attached and then a second measurement on the abutment.

13) Interpret the Result Implant StabilityAnimplantcanhavedifferentstabilityindifferentdirections.Thestability of the implant is dependent of the surrounding bone configuration.Thereisoftenadirectionwherethestabilityislowest, and a direction where the stability is highest and these two directionsaremostoftenperpendiculartoeachother.

Tofindtheloweststability(lowestISQvalue)itisrecommendedtomeasurefromtwodifferentdirections.Theloweststabilityisinmost cases found in the buccal-lingual direction. The highest stabil-ity is in most cases found in the mesial-distal direction.

The ISQ ValueAssuming there is access to the implant, ISQ measurements should be performed at implant placement and before the implant is load-edortheabutmentisconnected.Aftereachmeasurement,theISQvalues are recorded and used as the baseline for the next measurementperformed.AchangeintheISQvaluereflectsachange in implant stability. In general, an increase in ISQ values from one measurement time to the next indicates a progression

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towards higher implant stability while a decrease in ISQ values indicates a loss in stability and, possibly, implant failure. A stable ISQ value would indicate no change in stability.

14) Data Connection to Osstell ConnectThe Osstell Connect (osstellconnect.com) is an online tool for statistical analysis and valuable insights based on your data, with benchmarks against the entire Osstell Connect database. You can have your Osstell Beacon online connected to Osstell Connect for data collection. Before you can start using data connection to Osstell Connect you have to register your Osstell Beacon. The serial number can be found on the back of the instrument. For registration assistance and features of data connection to Osstell Connect, please visit: osstell.com/get-started-beacon

15) Cleaning and MaintenanceBeforeeachuse,moistenagauzeorsoftclothwithanacceptable(see list below) surface disinfectant and wipe the whole Osstell Beacon instrument.Note! Do not autoclave the Osstell Beacon instrument.Routinely check the surface of the instrument tip and overall surface for possible cracks and residuals.

Acceptable Cleaners:Isopropyl alcoholEthyl alcohol-based cleaners

Do not use:Strong alkali detergent of any type, including hand soaps and dish soaps Bleach based cleanersHydrogen Peroxide based cleanersAbrasive cleanersAcetone of hydrocarbon based cleanersMEK (Methyl Ethyl Ketone)BirexGluteraldehydeQuaternary Ammonium Chloride salt-based cleaners

The instrument does not require regular maintenance. In the event of an instrument malfunction, contact the local sales representative or distributor for further instructions.

SmartPegs: Delivered sterile. The SmartPegs™ are disposable and should only be used for one or multiple measurements at one treatment session, for a single patient only (to avoid cross-con-tamination).

TestPeg: Is not used intra-orally, does not require sterilization.

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The Smartpeg Mount should be cleaned and sterilized before each use according to the instructions below.

SmartPeg Mount: Must be autoclaved according to the recom- mended sterilization method, validated to sterility assurance levels (SAL), according to ISO 17665-1 and ISO 17664. The SmartPeg Mount should be placed in suitable packaging for the sterilization process.

Sterilization Exposure Exposure Method: temperature timePre-vacuum 132° C (270° F) 4 minPre-vacuum 134° C (273° F) 3 minGravity 134° C (273° F) 10 min

Warnings: do not exceed 135° C (275° F). Drying time: 30 minutes

Carefully inspect the Smartpeg Mount for damage or wear. Hand wash the Smartpeg Mount using a neutral instrument detergent. Rinse and dry; carefully inspect the Smartpeg Mount for damage and wear. Sterilize the Smartpeg Mount according to the auto-clave manufacturer´s instructions. Do not wash in dishwasher. Store sterile goods dust-free and dry.

16) Technical informationTechnical descriptionOsstell Beacon is CE-marked according to MDD in Europe (Class IIa, internally powered, type BF applied parts. Not AP or APG equip-ment, not protected against ingress of water).Osstell Beacon is in accordance with applicable parts of IEC 60601-1/ANSI/AAMI ES 60601-1.The symbols used, follow the European standard EN 60601-1 and ISO standards 9687 and 15223 as far as possible.

Notes on electromagnetic compatibility (EMC)Medical electrical equipment is subjected to particular precautions with regards to EMC and must be put into operation in accordance with the EMC notes included below:

Osstell guarantees the compliance of the device with the EMC requirements only when used with original accessories and spare parts. The use of other accessories / other spare parts can lead to an increased emission of electromagnetic interference or to a reduced resistance against electromagnetic interference.

YoucanfindthecurrentEMCmanufacturer’sdeclarationonourwebsite at osstell.com/products/Osstell-Beacon.Alternatively, you can obtain it directly from your local sales repre-sentative or distributor.

The Osstell Beacon contains a Bluetooth module.FCC ID: QOQBLE113, IC5123A-BGTBLE113

BatteryThe instrument contains a rechargeable lithium-ion battery.The instrument should be charged using the Osstell USB cable connected to a standard USB 2.0 or 3.0 type A outlet. Battery status and charging is indicated in the lower display with a battery symbol having 4 levels: 100 % (fully charged), 75 %, 50 % and less than 25%. When the level is less than 10 %, the Osstell Beacon will change the battery symbol to alert that it is time to charge the instrument.Note! It is not possible to perform an ISQ measurement duringcharging.

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AccuracyThe Osstell Beacon instrument has an ISQ accuracy/resolution of +/- 1 ISQ. When the SmartPeg is attached to an implant, the ISQ value can vary up to 2 ISQ depending on SmartPeg attachment torque.

Power, weight & size:

Lithium-ion battery: 3.7V DC

Charging: USB cable (USB type C / USB type A) connected to standard USB 2.0 or 3.0 (type A) outlet

Instrument size: 210 x 35 x 25 mm

Package size: 272 x 140,2 x 74,60 mm

Instrument weight: 0,07 kg

Gross weight: 0,75 kg

Environmental conditions during transport:

Temperature: -40º C to +70º C

Relative humidity: 10% to 95%

Pressure: 500 hPa to 1060 hPa

Environmental conditions during use:

Temperature: +10º C to +35º C

Relative humidity: 30% to 75%

Pressure: 700 hPa to 1060 hPa

IP class: IP20

17) Troubleshooting

No measurement or unexpected value

Re-Used SmartPeg. The SmartPegs™ are disposable and should only be used for one or multiple measurement at one treatment session, for a single patient only. Repeated re-use may result in false readings due to wearandtearofthesoftaluminiumSmartPegthreads.Wrong SmartPeg type selected for the Implant.See SmartPeg reference list, osstell.com/smartpegguideBone or soft tissue in between SmartPeg and Implant.Make sure to clean the Implant prosthetic connection before attaching the SmartPeg.

Electromagnetic interference. Remove the source of electromagnetic interference.Instrument tip is held too far away from the SmartPeg. Hold the instrument tip 3-5mm away from the SmartPeg.

Instrument does not sense the SmartPeg, hence no measure-ment.Perform a 2 cm circular movement of the instrument and then try to measure again.

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Unit is not charging when USB cable is connected

Wrong USB cable used.Only use Osstell USB cable connected to a standard USB type connector.

Instrument does not start

Uncharged battery.Charge the Osstell Beacon.

Instrument in transport mode. See section 7 for instruction on how to de-activate transport mode.

Instrument starts up with

Self-tests failedContact the local sales representative or distributor for further instructions.

The instrument does not show red-green-yellow color during start-upn

Theinstrumentwillflashred-yellow-greenduringstart-upasafunctional test of the color indication. If any or all colors are not shown, the instrument must not be used. Contact the local sales representative or distributor for further instructions.

Difficult to measure in an exact recommended directionn

No space, e.g. due to adjacent teeth. Trytomeasureataslightlydifferentangle.

Difficulties attaching the SmartPeg

Wrong SmartPegEnsure that the SmartPeg is compatible with the implant system.

18) Service and SupportIn the event of an instrument malfunction contact the local sales repre-sentative or distributor for further instructions.

19) Waste and DisposalThe Osstell Beacon instrument should be recycled as electrical equip-ment. SmartPegs should be recycled as metal. Whenever possible, the battery should be disposed in a discharged state to avoid heat generation through inadvertent short-circuiting.

Followyourlocalandcountry-specificlaws,directives,standardsandguidelines for disposal.

• Waste electrical equipment• Accessories and spare parts• Packaging

Osstell AB Stampgatan 14, 411 01 Göteborg, Sweden Phone: +46 31 340 82 50 | info@osstell.comwww.osstell.com

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